Ethics and the Pharmaceutical Industry. Edited by Michael A. Santoro and Thomas M. Gorrie, 492 pp, $40, ISBN 0-521-85496-2, New York, NY, Cambridge University Press, 2005.JAMA ReviewJAMA excerpt: [full text by subscription]
The pharmaceutical industry has had a prized business role insociety because of its ability to provide tools for treatingillness and alleviating human suffering. However, in recentyears public perception of pharmaceutical companies has becomeincreasingly negative.While the title Ethics and the Pharmaceutical Industry may suggesta paradox, Michael Santoro and Thomas Gorrie have compiled aseries of essays that provide a fair, balanced, and insightfulexamination of an increasingly troubled relationship betweenthe pharmaceutical industry and society. They highlight thatmuch of the challenge in this relationship is driven by an imperfectalignment of objectives. Society wants affordable, effective,and safe drugs. Businesses want to maximize profits. The freemarket brings these two sets of objectives together while providingpowerful incentives for creativity and innovation but also forbusinesses to restrict access to products and distort medicalpriorities.

NEJM excerpt: [full text by subscription]
Santoro and Gorrie have woven together a rich collection ofperspectives in Ethics and the Pharmaceutical Industry, withcontributors ranging from activists and academicians to regulatorsand representatives from the industry. Santoro, an academician,and Gorrie, who has a background in the industry, bring differentconceptual orientations to the work. In their words, Gorriebelieves “that healthcare is a commodity” and Santoro believes“that healthcare is a fundamental human right that circumscribesthe exercise of intellectual property.” They also hold differingviews of the proper role of government in the oversight of thepharmaceutical industry. These conflicting outlooks are reflectedin the contributed chapters, which provide accessible and nuanceddescriptions of the views of various stakeholders. The rangeof topics that are covered is quite broad, much like the reachof the industry itself. These topics include drug developmentand clinical testing, marketing and the availability of healthcare resources, and intellectual property and fair pricing.Because the contributors come from different camps, it wouldbe imprudent to read a single chapter with the assumption thatit offers a complete picture of a particular problem or issue.Rather, the book may prove to be the most useful in offeringchapters with competing perspectives. As such, the integrativework is left in large part to the reader, although introductorymaterial written by the editors preceding each major sectionprovides an overview.Another ReviewThe Law and Ethics of the Pharmaceutical Industry. by Graham Dukes, 409 pp, $129.95, ISBN 0-444-51868-1, San Diego, Calif, Elsevier, 2006.JAMA ReviewJAMA excerpt: [full text by subscription]
The preface of this book begins, “Any sector of society hasboth its written and unwritten rules of behaviour, which developand change as time goes by.” Graham Dukes, professor emeritusof Drug Policy Studies at the University of Groningen in theNetherlands, builds the entire book around that sentence. Hetraces the origins of laws, regulations, and codes of behaviordeveloped around the world to guide the pharmaceutical industry.In this regard, the book is very ambitious. It describes thehistory of the pharmaceutical industry and the definition ofstandards for that industry. It goes on to document the acceptanceand implementation of those standards in areas such as safety,demonstration of efficacy, and ensuring quality. It describesthe behavior of the industry in terms of pricing and profitsand its role in innovation and marketing. It covers the industryin both the developed and developing world and even deals withissues such as animal studies and the role of generic manufacturers.NEJM excerpt: [full text by subscription]
Dukes’s book, The Law and Ethics of the Pharmaceutical Industry,reflects the author’s background in medicine and law. In mappingthe wide range of policies and laws that relate to the pharmaceuticalindustry and the associated ethical issues, Dukes presents animportant set of background conditions. Commensurate with therelevant conditions at hand, the scope of the book is vast andincludes sections on business standards; standards for drugquality, safety, and efficacy; marketing and its relationshipto education; drug pricing; pharmaceutical innovation; issuesin the developing world; special situations (such as animaland human research, self-medication, controlled substances,alternative medicines, orphan drugs, and veterinary drugs);the manufacture of generic drugs; and areas of social controversy(such as the use of contraceptives and abortifacients and thepatenting of biologic materials). Although Dukes doesn’t attemptto catalogue all relevant laws, he provides categories and examplesthat serve as a useful starting point for understanding thetypes of policies and laws that should be considered in particularcases. In addition, Dukes includes stories that led to the adoptionof some of the laws and policies, which helps to make the processmore accessible to the reader.